AccessGUDID - DEVICE: Exhaust Collection Bag (00850008595028)

GUDID

Device Identifier (DI) Information

Brand Name: Exhaust Collection Bag
Version or Model: FGS-7005
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CHANNEL MEDSYSTEMS, INC.

Primary DI Number: 00850008595028
Issuing Agency: GS1
Commercial Distribution End Date: February 21, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 963415513 *Terms of Use

Device Description: Single exhaust collection bag in pouch

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45738	General cryosurgical system, cryogen gas, electronic	An assembly of electrically-powered devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to malignant or abnormal benign tissue for destruction and removal. The system includes an electronic control unit with LCD display to control the flow of cryogen from an attached cylinder, which might monitor skin temperature, and cryogen-cooled probes. It is intended for e.g., oncological, dermatological, oral, gynaecological, urological, proctological, or general surgical applications, however it is not dedicated to ophthalmic or cardiac surgery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNB	Device, Thermal Ablation, Endometrial

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P180032	001

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d8b2c460-d55a-4dfd-b004-47bba345dbb1
Public Version Date: March 25, 2025
Public Version Number: 2
DI Record Publish Date: August 21, 2020